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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthopedic stereotaxic instrument
Regulation Description Stereotaxic instrument.
Definition Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Product CodeOLO
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 8
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 8
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 181
Material deformation 156
Device operates differently than expected 81
Mechanical issue 56
Device or device component damaged by another device 39
Bent 35
Computer software issue 35
Device Issue 33
Unintended movement 24
No Known Device Problem 22
Imprecision 21
No Information 20
Detachment of device component 18
Vibration 14
Failure to fire 14
Temperature issue 13
Material integrity issue 12
Device inoperable 12
Use of Device Issue 11
Device displays error message 10
Detachment of device or device component 9
Device clogged 9
Positioning Issue 9
Noise, Audible 8
Electrical issue 8
Material fragmentation 8
Overheating of device or device component 8
Malposition of device 8
Computer operating system issue 7
Material twisted 7
Device Cleaning Issue 7
Dislodged or dislocated 7
Misassembled 6
Communication or transmission issue 6
Expiration date error 6
Component missing 5
Smoking 5
Improper device output 5
Output issue 4
Naturally worn 3
Metal shedding debris 3
Improper or incorrect procedure or method 3
Unstable 3
Occlusion within device 3
Loose or intermittent connection 3
Fracture 3
Disconnection 2
Application interface becomes non-functional or program exits abnormally 2
Blockage within device or device component 2
Component falling 2
Migration of device or device component 2
No device output 2
Material separation 2
Loss of power 2
Fitting problem 2
Size incorrect for patient 2
Calibration issue 2
Physical resistance 2
Mechanical jam 2
Power source issue 2
Patient Data Issue 2
Not Applicable 2
No code available 1
Data Issue 1
Device handling issue 1
Packaging issue 1
Environmental Particulates 1
Human-Device Interface Issue 1
Mechanics altered 1
Device packaging compromised 1
Device-device incompatibility 1
Connection issue 1
Slippage of device or device component 1
Sticking 1
Device stops intermittently 1
Device damaged prior to use 1
Failure to separate 1
Obstruction within device 1
Cut in material 1
Failure to power-up 1
Incorrect software programming calculations 1
Incorrect or inadequate result 1
Failure to read input signal 1
Difficult to position 1
Device emits odor 1
Incorrect measurement 1
Contamination during use 1
Loss of or failure to bond 1
Disassembly 1
Instruction for use issue 1
Inadequate instructions for healthcare professional 1
Total Device Problems 1021

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 1 1 0 2 5 3
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Blue Belt Technologies MN II May-09-2014
2 Brainlab AG II Feb-26-2015
3 Mako Surgical Corporation II Apr-29-2016
4 Mako Surgical Corporation II Apr-28-2016
5 Mako Surgical Corporation II Apr-18-2016
6 Mako Surgical Corporation II Nov-05-2015
7 Mako Surgical Corporation II Feb-19-2015
8 Mako Surgical Corporation II Dec-18-2014
9 Mako Surgical Corporation II Nov-19-2012
10 Mako Surgical Corporation II Nov-01-2011
11 Medtronic Navigation, Inc. II Sep-30-2015
12 Smith & Nephew Inc II Nov-18-2010
13 Zimmer CAS II Jun-02-2015

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